Cleared Traditional

K873485 - EDSLAB (R) OCCLUSION BALLOON CATHETER

K873485 is an FDA 510(k) clearance for EDSLAB OCCLUSION BALLOON CATHETER, manufactured by American Edwards Laboratories. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K873485 · American Edwards Laboratories · Cardiovascular device
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Dec 1987
Decision
94d
Days
Class 2
Risk

K873485 is an FDA 510(k) clearance for the EDSLAB (R) OCCLUSION BALLOON CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on December 3, 1987 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all American Edwards Laboratories devices

FDA 510(k) Submission Details - K873485

510(k) Number K873485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date December 03, 1987
Days to Decision 94 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 781
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K873485.
ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP
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K872163 · Impra, Inc. · Oct 1987
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K863791 · Gish Biomedical, Inc. · Jun 1987